Lani
01-27-2010, 03:35 PM
FDA Recalls Millions of Huber Needles
More than two million Huber needles -- used with implanted ports to treat chronic conditions -- have been recalled, the FDA announced.
The needles can cut the resealing silicone septum of the ports and possibly send slivers of the material into the body, with the potential to cause embolisms and other damage, according to Mary Brooks, RN, of the FDA's Center for Devices and Radiological Health.
The material could also lodge in the needle, restricting the flow of medication to the patient, Brooks told a telephone news conference announcing the Class I recall.
In a Class I recall, there is "a reasonable chance" that a product could cause serious health problems or death, according to the agency's Web site. But so far, Brooks said, there are no reports of adverse health events related to the recalled needles.
The recall affects needles made between January 2007 and August 2009 by Japan's Nipro Medical Corp. and imported by Exelint International Corp., of Los Angeles.
All Huber needles are supposed to be "non-coring" -- unable to cut the silicone of the port -- but the FDA had received reports from hospitals about leaking after ports were used.
Its own testing showed that some needles could cause coring and the agency began asking manufacturers to conduct their own tests.
Nipro tests showed that between 60% and 72% of needles could cut the silicone, according to Timothy Ulatowski, director of the office of compliance and the agency's Center for Devices and Radiological Health.
"That data set revealed the problem," he told reporters.
The company agreed to recall the needles voluntarily, he said.
Huber needles, first approved in 1983, are used together with implanted ports as part of a system to deliver medications by infusion when the drugs will be needed regularly for long periods.
They are used to treat diseases ranging from sickle cell anemia to breast cancer to osteoporosis, Brook said.
Until the testing showed a different result, she added, "we though Huber needles were by definition non-coring."
The finding was "a little bit surprising," she said.
Usually, when healthcare personnel use the ports, they aspirate a small amount of blood and then flush it back into the port reservoir.
The FDA is now recommending that healthcare personnel:
Avoid flushing the syringe.
Instead, when possible, aspirate a small amount of blood and then discard the syringe with its contents.
If the needle becomes clogged during aspiration, discard it and use another.
Keep an eye out for signs and symptoms that may indicate damage to the port's septum, including medication leakage resulting in inadequate drug delivery, tissue, nerve, or muscle damage, and redness of the surrounding area.
The recalled needles are a "significant number" of the six million Huber needles used every year in the U.S., but there is no worry about a shortage because there are 19 other manufacturers, according to Ulatowski.
The recalled needles have lot numbers that begin with either 07, 08, or 09, and one of the following product codes or catalog numbers:
Exel/Exelint Huber Needles Product Codes/Catalog Numbers: 26901, 26902, 26904, 26906, 26907, 26908, 26909, 26911, 26921, 26922,26923, 26924, and 26925
Infusion Sets Product Codes/Catalog Numbers With/Injection Site: 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, and 27950R
Infusion Sets Product Codes/Catalog Numbers Without/Injection Site: 27954R, 27955R, 27958R, and 27959R
Exel/Exelint "SecureTouch +" Safety Huber Sets Product Codes/Catalog Numbers: 37854S, 37855S, and 37858S
The current recall comes just days after Nipro recalled all its GlucoPro Insulin Syringes for fear that the needles can break off the syringe during injection.
More than two million Huber needles -- used with implanted ports to treat chronic conditions -- have been recalled, the FDA announced.
The needles can cut the resealing silicone septum of the ports and possibly send slivers of the material into the body, with the potential to cause embolisms and other damage, according to Mary Brooks, RN, of the FDA's Center for Devices and Radiological Health.
The material could also lodge in the needle, restricting the flow of medication to the patient, Brooks told a telephone news conference announcing the Class I recall.
In a Class I recall, there is "a reasonable chance" that a product could cause serious health problems or death, according to the agency's Web site. But so far, Brooks said, there are no reports of adverse health events related to the recalled needles.
The recall affects needles made between January 2007 and August 2009 by Japan's Nipro Medical Corp. and imported by Exelint International Corp., of Los Angeles.
All Huber needles are supposed to be "non-coring" -- unable to cut the silicone of the port -- but the FDA had received reports from hospitals about leaking after ports were used.
Its own testing showed that some needles could cause coring and the agency began asking manufacturers to conduct their own tests.
Nipro tests showed that between 60% and 72% of needles could cut the silicone, according to Timothy Ulatowski, director of the office of compliance and the agency's Center for Devices and Radiological Health.
"That data set revealed the problem," he told reporters.
The company agreed to recall the needles voluntarily, he said.
Huber needles, first approved in 1983, are used together with implanted ports as part of a system to deliver medications by infusion when the drugs will be needed regularly for long periods.
They are used to treat diseases ranging from sickle cell anemia to breast cancer to osteoporosis, Brook said.
Until the testing showed a different result, she added, "we though Huber needles were by definition non-coring."
The finding was "a little bit surprising," she said.
Usually, when healthcare personnel use the ports, they aspirate a small amount of blood and then flush it back into the port reservoir.
The FDA is now recommending that healthcare personnel:
Avoid flushing the syringe.
Instead, when possible, aspirate a small amount of blood and then discard the syringe with its contents.
If the needle becomes clogged during aspiration, discard it and use another.
Keep an eye out for signs and symptoms that may indicate damage to the port's septum, including medication leakage resulting in inadequate drug delivery, tissue, nerve, or muscle damage, and redness of the surrounding area.
The recalled needles are a "significant number" of the six million Huber needles used every year in the U.S., but there is no worry about a shortage because there are 19 other manufacturers, according to Ulatowski.
The recalled needles have lot numbers that begin with either 07, 08, or 09, and one of the following product codes or catalog numbers:
Exel/Exelint Huber Needles Product Codes/Catalog Numbers: 26901, 26902, 26904, 26906, 26907, 26908, 26909, 26911, 26921, 26922,26923, 26924, and 26925
Infusion Sets Product Codes/Catalog Numbers With/Injection Site: 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, and 27950R
Infusion Sets Product Codes/Catalog Numbers Without/Injection Site: 27954R, 27955R, 27958R, and 27959R
Exel/Exelint "SecureTouch +" Safety Huber Sets Product Codes/Catalog Numbers: 37854S, 37855S, and 37858S
The current recall comes just days after Nipro recalled all its GlucoPro Insulin Syringes for fear that the needles can break off the syringe during injection.